Status:
COMPLETED
Psychosis Associated With Methylphenidate in Children and Adolescents
Lead Sponsor:
University Hospital, Caen
Conditions:
Psychosis
Eligibility:
All Genders
5-17 years
Brief Summary
perform a study in VigiBase® to assess if methylphenidate was associated with an over-reporting of psychosis including hallucinations in children and adolescents and to characterize those psychosis.
Eligibility Criteria
Inclusion
- Case reported in the World Health Organization (WHO) database of individual safety case reports until 16/02/2024 in children and adolescents treated with drugs with an indication in ADHD.
- Adverse events reported were including a list of MedDRA Preferred Terms related to psychosis
Exclusion
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
January 1 1967
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
46233 Patients enrolled
Trial Details
Trial ID
NCT06518330
Start Date
January 1 1967
End Date
February 16 2024
Last Update
July 24 2024
Active Locations (1)
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1
Caen University Hospital, Department of Pharmacology
Caen, France